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NCT00036283 Clinical Trial

Chemoprevention of Oral Premalignant Lesions

Precancerous Conditions Clinical Trial

Official title:
Clinical Protocol For A Phase II Double-Blind, Placebo-Controlled, Randomized Study Of Celecoxib (Sc-58635) In Oral Premalignant Lesions, Investigator IND

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00036283
Other study ID # NQ4-00-02-011
Secondary ID
Status Completed
Phase Phase 2
First received May 8, 2002
Last updated September 25, 2008
Start date November 2000
Est. completion date April 2004

Study information
Verified date September 2008
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

Reduction in size and number of oral premalignant lesions

Recruitment information / eligibility
Status Completed
Enrollment 42
Est. completion date April 2004
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 8mm oral premalignant lesion that has not been biopsied in the past 6 months

Exclusion Criteria:

- Taking >100mg daily dose of NSAIDS (Non-steroidal anti-inflammatory drugs)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Drug:
• Celecoxib

Locations
Country Name City State
United States Pfizer Investigational Site Ann Arbor Michigan
United States Pfizer Investigational Site Farmington Connecticut
United States Pfizer Investigational Site Houston Texas
United States Pfizer Investigational Site Minneapolis Minnesota
United States Pfizer Investigational Site New York New York
United States Pfizer Investigational Site Seattle Washington
United States Pfizer Investigational Site Shreveport Louisiana

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary To evaluate the efficacy of celecoxib in subjects with Early or Advanced oral premalignant lesion (OPL)
Primary by both clinical response (reduction in size of all lesions,
Primary prevention of growth in the index lesion and of any new lesions)
Primary and histological response (change in histological grade).
Primary To evaluate the safety of chronic multiple dosing of celecoxib in this patient population.
Secondary To evaluate the treatment effects in modulating the expression of genomic and proliferative markers after 12 weeks of treatment with study drug, followed by 12 weeks off study drug.
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